(dar a TOOM ue mab)
Trade Name: Darzalex®
Daratumumab is the generic name for the trade name drug Darzalex. In some cases, health care professionals may use the trade name Darzalex when referring to the generic drug name daratumumab.
Drug Type: Daratumumab is an anti-cancer ("antineoplastic" or "cytotoxic") drug. This medication is a monoclonal antibody directed against CD38, a molecule present on myeloma cells. (For more detail, see "How Daratumumab Works" below)
What Daratumumab Is Used For:
- Treatment of multiple myeloma that was refractory to a combination of a proteasome inhibitor such as bortezomib (Velcade), ixazomib (Ninlaro) or carfilzomib (Kyprolis) and an immunomodulatory drug such as lenalidomide (Revlimid), thalidomide (Thalomide) or pomalidomide (Pomalyst) or that requires treatment after 3 or more lines of prior therapy that included a proteasome inhibitor and an immunomodulatory drug.
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Daratumumab Is Given:
- As an infusion into a vein (intravenous, IV) over about 8 hours with the first infusion. The time of the infusion may be shortened or extended, depending on how well you tolerate this drug after the first infusion.
- Medications will be given one hour before the infusion to reduce the occurrence of infusion-related symptoms.
- You may receive some medications after the infusion to prevent delayed infusion-related symptoms.
- There is no pill form of daratumumab.
- The usual schedule for daratumumab infusions is 8 weekly treatments, then 8 more treatments given every other week (over a 16 week period of time), then a treatment every 4 weeks.
The amount of daratumumab that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.
Important things to remember about the side effects of daratumumab:
- Most people will not experience all of the daratumumab side effects listed.
- Daratumumab side effects are often predictable in terms of their onset, duration, and severity.
- Daratumumab side effects will improve after therapy is complete.
- Daratumumab side effects may be quite manageable.
- There are many options to minimize or prevent the side effects of daratumumab.
The following side effects are common (occurring in greater than 20%) for patients taking daratumumab:
A serious infusion reaction is an uncommon side effect of daratumumab. When this side effect occurs, it usually occurs with the first infusion. It may cause severe shortness of breath, high or low blood pressure, cough, wheezing, hives, itching, rash, nausea, vomiting, or chills. Symptoms are treatable and almost always resolve quickly so that the daratumumab dose can still be safely administered. Patients are monitored closely during infusions so that appropriate treatment can be given and the daratumumab infusion temporarily be stopped if an infusion reaction occurs.
Not all side effects are listed above. Side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.
When To Contact Your Doctor of Health Care Provider:
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
- Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)
The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
- Nausea (interferes with ability to eat and unrelieved with prescribed medication)
- Vomiting (vomiting more than 4-5 times in a 24 hour period)
- Diarrhea (4-6 episodes in a 24-hour period)
- Unusual bleeding or bruising
- Black or tarry stools, or blood in your stools
- Blood in the urine
- Pain or burning with urination
- Extreme fatigue (unable to carry on self-care activities)
- Mouth sores (painful redness, swelling or ulcers)
Always inform your health care provider if you experience any unusual symptoms.
- Before starting daratumumab treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.) Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
- Do not receive any kind of immunization or vaccination without your doctor's approval while taking daratumumab.
- Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (Daratumumab may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus). This drug should not be given to a pregnant woman or a woman who intends to become pregnant. If a woman becomes pregnant while taking daratumumab, the medication must be stopped immediately and the women given appropriate counseling.
- For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking daratumumab. Barrier methods of contraception, such as condoms, should be used during treatment and for 3 months after last dose of daratumumab.
- Do not breast feed while taking daratumumab.
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
- You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
- Wash your hands often.
- Use an electric razor and a soft toothbrush to minimize bleeding.
- Avoid contact sports or activities that could cause injury.
- To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
- Avoid sun exposure Wear SPF 30 (or higher) sunblock and protective clothing.
- In general, drinking alcoholic beverages should be avoided completely. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
- If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
Monitoring and Testing:
You will be checked regularly by your doctor while you are taking daratumumab, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.
A type and screen blood test should be done before you start daratumumab. If you require a blood transfusion after starting daratumumab, the blood bank should be informed that you are receiving this medication as it masks antibody detection to minor antigens in your blood. Your ABO and Rh blood type are not affected.
This treatment may affect some of the blood work your provider used previously to monitor your multiple myeloma. Your provider may monitor your myeloma in a different way after starting this therapy.
How Daratumumab Works:
Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cell if that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.
Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of cancer cells to grow, divide, repair and/or communicate with other cells.
There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.
Researchers agree that targeted therapies are not a replacement for traditional therapies. They may best be used in combination with traditional therapies. More research is needed to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.
Daratumumab is a targeted therapy (IgG1k human monoclonal antibody) that targets CD38. Cd38 is a cell surface glycoprotein which is highly expressed on myeloma cells. It is expressed at low levels on normal myeloid and lumphoid (normal) type of white blood cells. When daratumumab binds to CD38, it inhibits the growth of CD38 expressing tumor cells and induces apoptosis (cell death) directly through mediated cross linking and by immune mediated tumor cell lysis through complement dependent cytotoxicity, antibody cell mediated cytotoxicity, and antibody dependent cellular phagocytosis.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and education, but is not a substitute for medical advice.